淫羊藿配方颗粒制备工艺优化及一致性评价

Optimization and Consistency Evaluation of Preparation Process of Yinyanghuo Dispensing Granules

目的探讨淫羊藿配方颗粒制备工艺的优化及一致性评价。方法采用L9(3^4)正交试验,以出膏率、淫羊藿总黄酮和淫羊藿苷含量为评价指标,考察浸泡时间、加水量、提取时间、提取次数对提取工艺的影响,筛选最佳提取工艺。饮片经最佳工艺提取后,减压浓缩、喷雾干燥、干法制粒制备配方颗粒。通过特征成分的含量测定比较饮片-中间体-配方颗粒间量值传递的相关性。结果最佳提取工艺为浸泡0.5 h,加12倍量水,煎煮3次,每次煎煮1.5 h。结论淫羊藿水煎提取工艺稳定,重复性好。淫羊藿饮片-中间体-配方颗粒中淫羊藿苷含量呈量值传递关系,一致性较好,可为生产提供参考。

Objective To investigate the optimization and consistency evaluation of the preparation process of Yinyanghuo Dispensing Granules.Methods Orthogonal test L9(34)was used to evaluate the effects of soaking time,icariin on the extraction process,the amount of water added,the extraction time and the number of extractions.After the herbal was extracted by the best process,the formula particles were prepared by vacuum concentration,spray drying,and dry granulation.The correlation of the amount transfer between the decoction piece-extract solution-fluid extract-dispensing granules was compared by the content of the characteristic components.Results The best extraction process was to soak for 0.5 h,add 12 times the amount of water,and 3 times of decoction for 1.5 h each time.Conclusion The decoction extraction process of Epimedium brevicornu is stable and reproducible.The content of icariin in decoction piece-extract solution-fluid extract-dispensing granules shows a quantitative transfer relationship,which has good consistency and provided basis for production.